Role Summary
Medical Director, Clinical Development is a key clinical leader responsible for the design, execution, and interpretation of clinical trials supporting the development of innovative therapies within Disc's pipeline. Provides strategic and scientific leadership to cross-functional teams, ensuring clinical programs meet regulatory, ethical, and corporate objectives. Supports a clinical-stage program focused on iron metabolism and anemia treatment using a novel, first-in-class negative regulator of hepcidin.
Responsibilities
- Clinical Strategy & Leadership
- Contribute to the overall clinical development strategy for assigned programs.
- Define clinical development plans, trial designs, and program milestones in partnership with senior leadership.
- Provide medical and scientific input into target product profiles, study protocols, investigator brochures, and regulatory documents.
- Monitor internal and external developments that could impact the development plan and review relevant literature.
- Evaluate information about diseases and competitive landscape to support development programs and strategic planning.
- Identify appropriate advisory board experts.
- Clinical Trial Oversight
- Serve as medical monitor for clinical trials, ensuring subject safety and data integrity.
- Provide clinical guidance to operational teams, investigators, and external partners.
- Review and interpret clinical data, prepare clinical study reports, and support publication activities.
- Oversee clinical content of protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs, and clinical expert reports.
- Organize and present at clinical advisory boards, DMC, and medical/scientific meetings.
- Cross-Functional Collaboration
- Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Medical Affairs to ensure execution of programs.
- Represent Clinical Development in governance meetings and cross-functional program teams.
- Support business development and alliance management as needed.
- Regulatory & Compliance
- Contribute to regulatory submissions (INDs, NDAs, BLAs) and interactions with global health authorities.
- Ensure compliance with GCP, ICH guidelines, and SOPs.
- Scientific Communication & Leadership
- Prepare abstracts and manuscripts for publication/presentation.
- Present clinical data to internal stakeholders, investigators, and at scientific conferences.
- Mentor junior medical or scientific staff.
Qualifications
- MD with research experience or MD/PhD, fellowship in Hematology/Oncology or related areas, 10–12 years of related experience.
- Extensive translational or clinical research experience in drug development; biotech/pharma experience preferred.
- Experience developing clinical regulatory strategy.
- Strong academic record with peer-reviewed publications.
- Proven cross-functional collaboration within an organization and with external partners.
- Expertise in data analysis and presentation; knowledge of clinical research methodology, statistics, and interpretation.
- Effective written and oral communication with internal and external stakeholders.
- Experience interacting with management, academicians, clinicians, and scientists; regulatory submissions/interactions with FDA/EMA preferred.
- Ability to travel up to 20% for investigator meetings, regulatory interactions, or conferences.
Skills
- Clinical strategy and leadership
- Medical monitoring of trials
- Regulatory submissions and compliance
- Data analysis and interpretation
- Scientific communication and mentorship
Education
- MD (or equivalent) with relevant subspecialty training; MD/PhD considered.